Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial.
Arch Gynecol Obstet
; 301(6): 1463-1471, 2020 06.
Article
em En
| MEDLINE
| ID: mdl-32314015
ABSTRACT
PURPOSE:
This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD).METHODS:
We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 11 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects.RESULTS:
Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3; p < 0.001). Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 ± 1.0 vs 5.9 ± 0.8; p < 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 ± 1.1 vs 5.9 ± 1.1; p < 0.001) and (5.6 ± 0.9 vs 7.2 ± 0.8; p < 0.001), respectively. Adverse events were not significantly different between both groups.CONCLUSION:
Dinoprostone administration 2 h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30 min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Ocitócicos
/
Dinoprostona
/
Cesárea
/
Levanogestrel
/
Contraceptivos Hormonais
/
Dispositivos Intrauterinos Medicados
Tipo de estudo:
Clinical_trials
/
Observational_studies
Limite:
Adult
/
Female
/
Humans
/
Pregnancy
Idioma:
En
Revista:
Arch Gynecol Obstet
Assunto da revista:
GINECOLOGIA
/
OBSTETRICIA
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Egito